K191371 is an FDA 510(k) clearance for the MolecuLight i:X. This device is classified as a Autofluorescence Imaging Adjunct Tool For Wounds (Class II — Special Controls, product code QJF).
Submitted by Moleculight, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 4, 2019, 196 days after receiving the submission on May 22, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4550. An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis..
| 510(k) Number | K191371 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 22, 2019 |
| Decision Date | December 04, 2019 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QJF — Autofluorescence Imaging Adjunct Tool For Wounds |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4550 |
| Definition | An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis. |